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The Effect of Intra-vaginal Conjugated Estrogen Cream on Ring Pessary Use for Pelvic Organ Prolapse

Primary Purpose

Pelvic Floor Prolapse

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Vaginal Cream with Applicator [Dose Form]
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Floor Prolapse focused on measuring Vaginal estrogen cream

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Symptomatic POP, stage II, stage III or stage IV
  2. Postmenopausal women (patients with serum FSH>40lu/L; or amenorrhea for 12 months)
  3. Successfully fit with ring with support pessary
  4. Ability to attend the clinical trial and follow-up
  5. Patients and their families understand the study, are willing to participate for up to 1 year and can provide written informed consent
  6. Willing and able to place vaginal cream

Exclusion Criteria:

  1. Acute infection of internal genital tract
  2. Hormone replacement therapy in recent 3 months
  3. Suspected or untreated lower genital tract tumor
  4. Genital fistula
  5. Abnormally elevated intra-abdominal pressure (eg ascites, tumor, etc)
  6. Life expectancy less than 1 year
  7. Vaginal estrogen contraindications, including known or suspected estrogen dependent malignancies (endometrial carcinoma, melanoma), endometrial hyperplasia (thickness of endometrium≥5mm), thrombophlebitis or thromboembolic disease, undiagnosed irregular vaginal bleeding, known or suspected breast cancer, allergy to any component of the estrogen cream and severe liver disease, breast cancer
  8. The volume of post-voiding residual is more than 250ml. -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Vaginal estrogen cream

    vaginal placebo cream

    Arm Description

    subjects will be treated with the prescribed vaginal medication, 1g per time, q d for the first 2 weeks and then 1g per time, twice a week.

    Subjects will be treated with the prescribed vaginal medication, 1g per time, q d for the first 2 weeks and then 1g per time, twice a week.

    Outcomes

    Primary Outcome Measures

    The proportion of subjects using the pessary and have very much or much improvement on the patient impression of improvement questionnaire at 1 year between the vaginal estrogen group and the placebo group.
    Sustained wearing with satisfaction: continuous wearing is defined as the use of the pessary after successful fitting test. The continuous wearing time interval is from the start of wearing the pessary to cessation of pessary use. PGI-I （patient global impression of improvement））is used to evaluate patient impression of improvement. PGI-I is divided into seven levels: very much better, much better, a little bit better, no change, a little bit worse, much worse and very much worse. The patient's response of" very much better" and" much better" is defined as a successful impression of improvement.

    Secondary Outcome Measures

    1. Comparison of symptom specific distress (PFDI-20) at 6 months and one year in subjects using the pessary in the vaginal estrogen group and the placebo group at 1 year.
    Questionnaire survey: Relief of symptoms using validated instruments, Pelvic Floor Distress Inventory-20 。PFDI-20 scores 0-300, The higher the score is, the more serious the symptoms of PFD are, the greater the impact on the life of the patients.
    1. Comparison of symptom specific impact (PFIQ-7) at 6 months and one year in subjects using the pessary in the vaginal estrogen group and the placebo group at 1 year.
    Questionnaire survey: Relief of symptoms using validated instruments, pelvic floor impact questionnaire short form 7(PFIQ-7)。PFIQ-7 scores 0-300, the higher the severer negative influence on patient.
    1. Comparison of sexual function (PISQ-12) at 6 months and one year in subjects using the pessary in the vaginal estrogen group and the placebo group at 1 year.
    Questionnaire survey: Relief of symptoms using validated instruments, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form(PISQ-12), PISQ-12 scores 0-48, the higher, the severer negative influence on patient.
    Comparison of the adverse events of subjects wearing a pessary in the vaginal estrogen group and the placebo group at 1 year.
    Complications will be asked and reported during each follow-up

    Full Information

    First Posted
    May 10, 2020
    Last Updated
    May 13, 2020
    Sponsor
    Peking Union Medical College Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04393194
    Brief Title
    The Effect of Intra-vaginal Conjugated Estrogen Cream on Ring Pessary Use for Pelvic Organ Prolapse
    Official Title
    The Effect of Intravaginal Conjugated Estrogen on Ring Pessary Use for Pelvic Organ Prolapse: A Multicenter Randomized, Double- Blind, Placebo Controlled, Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 24, 2020 (Anticipated)
    Primary Completion Date
    June 1, 2022 (Anticipated)
    Study Completion Date
    September 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking Union Medical College Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The primary purpose of this two-arm randomized clinical trial is to determine if in women desiring use of a pessary for pelvic organ prolapse (POP) and are successfully fit, if 1-year use and patient impression of improvement is superior in women using vaginal estrogen cream versus those using a vaginal placebo cream.
    Detailed Description
    The study is a multi-center, randomized trial of women with symptomatic utero-vaginal or post-hysterectomy vaginal vault prolapse desiring non-surgical treatment with a pessary. This study will compare outcomes in women randomized to vaginal estrogen cream or vaginal placebo cream. Women who meet the inclusion/exclusion criteria will be evaluated. A pessary (ring with support) will be fit by an experienced physician. After successful pessary fitting, they will be randomly divided into experimental active medication and control groups. The experimental group will start intravaginal estrogen cream, and the control group will start intravaginal estrogen-free cream. Then patients will be followed every 3months until 1year. The purpose of this trial is to evaluate the effect of intravaginal estrogen use on pessary treatment for pelvic organ prolapse, including short-term and long-term use rate, patient impression of improvement, improvement in symptom-specific quality of life and complication incidence.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pelvic Floor Prolapse
    Keywords
    Vaginal estrogen cream

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Two-arm,Randomized, Double- Blind, Placebo Controlled, Clinical Trial
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    420 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Vaginal estrogen cream
    Arm Type
    Experimental
    Arm Description
    subjects will be treated with the prescribed vaginal medication, 1g per time, q d for the first 2 weeks and then 1g per time, twice a week.
    Arm Title
    vaginal placebo cream
    Arm Type
    Placebo Comparator
    Arm Description
    Subjects will be treated with the prescribed vaginal medication, 1g per time, q d for the first 2 weeks and then 1g per time, twice a week.
    Intervention Type
    Drug
    Intervention Name(s)
    Vaginal Cream with Applicator [Dose Form]
    Other Intervention Name(s)
    pessary
    Intervention Description
    Patients with symptomatic POP will be assigned as outpatients. After the initial pessary fitting, the patients will be followed up in 2 weeks. If the prolapse is supported, no discomfort, and the patient decides to continue to use the pessary, the pessary fitting is successful. Patients with successful ring pessary fitting, who agree to participate and sign written consent, will be randomized into the vaginal estrogen group and the placebo group. The patients will be followed up every 3 months after wearing pessary combined with vaginal medication, until 1 year after wearing the pessary.
    Primary Outcome Measure Information:
    Title
    The proportion of subjects using the pessary and have very much or much improvement on the patient impression of improvement questionnaire at 1 year between the vaginal estrogen group and the placebo group.
    Description
    Sustained wearing with satisfaction: continuous wearing is defined as the use of the pessary after successful fitting test. The continuous wearing time interval is from the start of wearing the pessary to cessation of pessary use. PGI-I （patient global impression of improvement））is used to evaluate patient impression of improvement. PGI-I is divided into seven levels: very much better, much better, a little bit better, no change, a little bit worse, much worse and very much worse. The patient's response of" very much better" and" much better" is defined as a successful impression of improvement.
    Time Frame
    up to 1year after randomization
    Secondary Outcome Measure Information:
    Title
    1. Comparison of symptom specific distress (PFDI-20) at 6 months and one year in subjects using the pessary in the vaginal estrogen group and the placebo group at 1 year.
    Description
    Questionnaire survey: Relief of symptoms using validated instruments, Pelvic Floor Distress Inventory-20 。PFDI-20 scores 0-300, The higher the score is, the more serious the symptoms of PFD are, the greater the impact on the life of the patients.
    Time Frame
    up to 1year after randomization
    Title
    1. Comparison of symptom specific impact (PFIQ-7) at 6 months and one year in subjects using the pessary in the vaginal estrogen group and the placebo group at 1 year.
    Description
    Questionnaire survey: Relief of symptoms using validated instruments, pelvic floor impact questionnaire short form 7(PFIQ-7)。PFIQ-7 scores 0-300, the higher the severer negative influence on patient.
    Time Frame
    up to 1year after randomization
    Title
    1. Comparison of sexual function (PISQ-12) at 6 months and one year in subjects using the pessary in the vaginal estrogen group and the placebo group at 1 year.
    Description
    Questionnaire survey: Relief of symptoms using validated instruments, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form(PISQ-12), PISQ-12 scores 0-48, the higher, the severer negative influence on patient.
    Time Frame
    up to 1year after randomization
    Title
    Comparison of the adverse events of subjects wearing a pessary in the vaginal estrogen group and the placebo group at 1 year.
    Description
    Complications will be asked and reported during each follow-up
    Time Frame
    up to 1year after randomization

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Symptomatic POP, stage II, stage III or stage IV Postmenopausal women (patients with serum FSH>40lu/L; or amenorrhea for 12 months) Successfully fit with ring with support pessary Ability to attend the clinical trial and follow-up Patients and their families understand the study, are willing to participate for up to 1 year and can provide written informed consent Willing and able to place vaginal cream Exclusion Criteria: Acute infection of internal genital tract Hormone replacement therapy in recent 3 months Suspected or untreated lower genital tract tumor Genital fistula Abnormally elevated intra-abdominal pressure (eg ascites, tumor, etc) Life expectancy less than 1 year Vaginal estrogen contraindications, including known or suspected estrogen dependent malignancies (endometrial carcinoma, melanoma), endometrial hyperplasia (thickness of endometrium≥5mm), thrombophlebitis or thromboembolic disease, undiagnosed irregular vaginal bleeding, known or suspected breast cancer, allergy to any component of the estrogen cream and severe liver disease, breast cancer The volume of post-voiding residual is more than 250ml. -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lan Zhu
    Phone
    +86-69156874
    Email
    zhu_julie@vip.sina.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ying Zhou
    Phone
    +86-69156204
    Email
    shellypumch@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Relying on sharing of online database
    IPD Sharing Time Frame
    starting 6 months after publication
    IPD Sharing URL
    http://www.chictr.org.cn/index.aspx

    Learn more about this trial

    The Effect of Intra-vaginal Conjugated Estrogen Cream on Ring Pessary Use for Pelvic Organ Prolapse

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